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September 15, 2009

Glaxo E-Mails Over Paxil Study Must Be Turned Over

GlaxoSmithKline Plc’s e-mail with researchers studying birth defects allegedly caused by the drugmaker’s antidepressant Paxil must be turned over to a family suing over the drug.

U.S. District Judge Nancy Gertner in Boston refused to block William Seale’s family from reviewing e-mails and other communications between Glaxo and Boston University researchers over Paxil’s birth-defect risks.

The 1-year-old, whose pregnant mother took the antidepressant, died in 2004 after three surgeries to address heart defects, according to court filings.

The family contends officials at London-based Glaxo, which funded the birth-defect research, sought to influence the study’s results to help protect the company from lawsuits, Gertner said in her ruling. The study was done at the university’s Slone Epidemiology Center.

“The plaintiffs are entitled to correspondence and documents between anyone at Slone and GSK about the study, its scope” and methodology, the judge concluded, referring to the company by its stock ticker.

The ruling came on the eve of Glaxo’s first trial of claims that Paxil caused birth defects. Opening statements began today in state court in Philadelphia. The company faces about 600 such cases across the U.S.

Paxil, approved by the FDA in 1992, generated about $942 million in sales last year, 2.1 percent of the total for the company.

Glaxo, the world’s second-largest drugmaker, has faced a spate of suits over the anti-depressant alleging it created increased risk of suicide in some users and birth defects in the children of other users.

As part of yesterday’s decision, Gertner denied the family’s request to access the study’s raw data. The judge ordered Boston University researchers Allen Mitchell and Carol Louik to turn over other information about their contacts with the drugmaker.

Some of that information relates to communications Glaxo had with the researchers as they prepared to submit the study to the New England Journal of Medicine for publication, according to Gertner’s order. The study was published in 2007.

The university argued that if it were forced to turn over data, scientists may be less inclined to research issues that could be the basis for litigation.

Boston University agreed to turn over correspondence between Slone and Glaxo before Gertner’s decision, he said. Glaxo didn’t influence the study’s results, he said.

Lawyers for the infant’s family, who sued Glaxo in federal court in Mississippi, alleged company officials pushed Mitchell and Louik to make changes in the study’s architecture, according to court filings.

GSK’s employees recommended changes which ultimately were made to the study, the family’s lawyers argued in a July 24 court filing. “That fact was never reported, nor was the fact that GSK employees were telling researchers how to present the data,” they said.

The family’s attorneys said Glaxo sent the Slone scientists an e-mail in June 2006, seeking access to study information so the drugmaker’s lawyers and experts could use it to defend against the suit.

“Litigation in the U.S. has now begun following the recent observations from epidemiological studies regarding the risks of congenital malformations in infants whose mothers” took Paxil while pregnant, the e-mail said. Gertner read the missive’s full text into the court record at an Aug. 20 hearing.

“In relation to this legal activity, GSK’s legal team would like to provide potential expert witnesses with various study reports including your Slone Epidemiology Center report that you prepared and provided to GSK in January 2006,” the e- mail said.

Officials of the Slone Center countered that Glaxo executives didn’t alter the outcome of the Paxil study and that the e-mail was irrelevant to the study’s results.

The center’s research contract with Glaxo “gave final authority to Slone for all editorial and content-based decisions,” Louik said in an affidavit filed with the court.

Slone received suggestions in 2006 from Glaxo for changes in the manuscript to be submitted to the New England Journal of Medicine, Louik said. “We rejected all of GSK’s suggestions that might have served to weaken our findings and conclusions,” she said in the affidavit.

“GSK suggested that our ‘overall’ findings did not support the hypothesis that Paxil increases the risk of cardiac defects. We rejected that suggestion as well.”
Glaxo officials “were free to make suggestions, which we considered, but we made up our own minds about the best way to present the work,” she added.

The researchers’ decision to let Glaxo share the report with its legal team didn’t mean the scientists were influenced by the drugmaker, Louik added.

“I was never pressured to make changes that might have benefited GSK in a lawsuit,” she said in the affidavit. The published report, using additional study subjects, “strengthened the association of Paxil with birth defects,” she said.

Lawyers for the family of 3-year-old Lyam Kilker may seek to convince jurors in Philadelphia that Glaxo officials sought to improperly influence researchers as part of the company’s campaign to fend off birth defect lawsuits.

Lyam was born with two holes in his heart as a result of the drug, his mother said in court papers. The infant underwent multiple surgeries within six months of his birth, she added.

Lawyers for the company countered at a Sept. 3 pretrial hearing that there is no evidence David was taking Paxil at the time Lyam was conceived and that the company acted responsibly in testing Paxil and updating safety information.

Glaxo is also fighting suits in the U.S., Canada and the U.K. over claims that Paxil, also known by the generic name paroxetine, causes homicidal and suicidal behavior. The company has settled some suicide claims, though terms of the settlements haven’t been released.

In 2004, the drugmaker agreed to pay the state of New York $2.5 million to resolve claims that officials suppressed research showing Paxil may increase suicide risk in young people. The settlement also required Glaxo to publicly disclose the studies.

The Mississippi case is Seale v. SmithKlineBeecham Corp, 1:07-cv-00180, U.S. District Court, Northern District of Mississippi.

Gertner’s ruling came in a motion filed in case 09-10198, U.S. District Court, District of Massachusetts (Boston). The Philadelphia case is Kilker v. SmithKline Beecham Corp., 2007- 001813, Court of Common Pleas, Philadelphia County, Pennsylvania.

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